Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
The Wichita facility has been in the news recently, as the company received a warning letter from the FDA after an inspection ... of 1.46 EUR for a forward P/E ratio of 12 based on next year ...
Some workers at the Environmental Protection Agency (EPA) have received a letter from the agency warning them that they may face termination amid the Trump administration's efforts to scale back ...
A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in ...
Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a ...
The DGCA issued a warning letter to Akasa for lapses in dangerous goods carriage found during a December 2024 inspection. Violations included unchecked electronic devices with lithium batteries ...
In the words of The Carpenters', "We've Only Just Begun!," I hate the news. Yet, each day I make myself look to see what Donald Trump and his mighty pen have done. The convicted felon has pardoned ...
The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning about the risk of developing Guillain-Barré syndrome (GBS), a rare ...
He also said the agency only used the exact text required by law for two out of its 11 warning labels. The FDA recommended new health warnings with color images for cigarette packages and ...
WASHINGTON, Jan. 8, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. Vanda Logo (PRNewsfoto/Vanda ...
SEBI warned Ola Electric for violating disclosure norms by announcing expansion plans on social media before notifying the stock exchanges. Bhavish Aggarwal posted about the store expansion on X ...